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| Name | Class |
|---|---|
| Picterus AS | INDUSTRY |
| Instituto Mexicano del Seguro Social | OTHER_GOV |
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The performance and accuracy of the smartphone application (app) Picterus Jaundice Pro (PicterusJP) will be validated by a cross-sectional study conducted in low resource settings in Mexico. Physics-based and machine learning-based models will be used to analyze the images obtained with the app and its performance will be compared.
A cross-sectional prospective study is taken place at Hospital General de Zona 1 in the city of Oaxaca, Mexico.
Participants are recruited from the maternity ward and emergency room and data collection is conducted by one experienced pediatrician and one paediatrics' resident. After informed consent is obtained, background data including time and date or birth, birth weight, gestational age, parent's skin type according to Fitzpatrick scale and newborn's skin color according to Neomar's scale is being collected. Visual assessment is performed by the researchers using Kramer's scale. To obtain the bilirubin measurements with the smartphone app Picterus Jaundice Pro (Picterus JP), the calibration card is placed on the newborn's chest and a set of six images, 3 with and 3 without flash, are captured. The smartphones used to capture the images are Samsung A23, iPhone 11 and iPhone 15 Pro.
Total serum bilirubin (TSB) levels are measured with a blood sample obtained within one hour of capturing the images and analyzed at the hospital laboratory facilities.
Demographic and clinical characteristics will be analyzed by descriptive statistic.
Bilirubin measurements correlation between Picterus JP using both models and TSB will be determined by Pearson's correlation coefficient. Systematic over or underestimation of bilirubin levels will be evaluated using Bland-Altman plots. Accuracy measurements will be determined using receiver operating characteristics (ROC) and area under the curve (AUC) analysis. To compare the correlations from both models, Fisher's r to z transformation approach will be applied
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Screening for neonatal jaundice with a mobile health device | Experimental | Neonatal jaundice will be screened using the app Picterus JP and the results will be compared to the total serum bilirubin level from a blood test. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Screening for neonatal jaundice with a mobile health device | Device | Picterus Jaundice Pro will be used to screen for neonatal jaundice by taking 6 photos of the newborns skin, where the Picterus calibration card is place. |
| Measure | Description | Time Frame |
|---|---|---|
| Enable high qualitative estimation of bilirubin levels in the blood of Mexican newborns using Picterus JP | Evaluate the smartphone-based screening tool Picterus for neonatal jaundice in Mexican newborns. | 16 months |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation between bilirubin measurements with Picterus JP and total serum bilirubin | Pearson correlation coefficient | 2 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Accuracy of Picterus JP to screen for neonatal jaundice | Sensitivity, specificity, positive and negative predictive values | 16 months |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital General de Zona 1 | Oaxaca City | 68040 | Mexico |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40612198 | Derived | Jimenez-Diaz G, Gierman LM, Keitsch M, Elizarraras-Rivas J, Silva-Mendez RM, Infanti JJ, Marcuzzi A. Validation of a Mobile Health Device for Neonatal Jaundice Screening: A Cross-Sectional Study in a Resource-Limited Setting in Mexico. Sage Open Pediatr. 2025 Apr 22;12:30502225251320544. doi: 10.1177/30502225251320544. eCollection 2025 Jan-Dec. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jul 9, 2025 | |
| Reset | Jul 29, 2025 | |
| Release | Aug 4, 2025 | |
| Reset | Aug 20, 2025 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jul 9, 2025 | Jul 29, 2025 | |||
| Aug 4, 2025 |
| ID | Term |
|---|---|
| D007567 | Jaundice, Neonatal |
| ID | Term |
|---|---|
| D051556 | Hyperbilirubinemia, Neonatal |
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006932 | Hyperbilirubinemia |
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| ID | Term |
|---|---|
| D008403 | Mass Screening |
| ID | Term |
|---|---|
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D006306 | Health Surveys |
| D011795 | Surveys and Questionnaires |
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| Aug 20, 2025 |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D003954 | Diagnostic Services |
| D011314 | Preventive Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| D015980 | Public Health Practice |